Study on the Relationship of Arterial-venous Oxygen Difference and Postoperative Complications After Cardiac Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)
研究概览
简要总结
Avoidance of unnecessary blood transfusions has always been a focus of clinical research. The rate of perioperative red blood cell transfusion in patients undergoing cardiac surgery under cardiopulmonary bypass reaches between 50-70%, and the intraoperative red blood cell transfusion rate is 30-50%. Regarding whether and when to perform a blood transfusion, it is necessary to comprehensively consider the benefits and risks brought by blood transfusion.
Previous studies on blood transfusion strategies have mainly focused on the hemoglobin threshold, but the hemoglobin level does not fully reflect the level of tissue oxygenation. Mixed venous blood oxygen saturation has been widely studied as a valuable indicator reflecting the balance of oxygen delivery and oxygen consumption. But due to the difficulty of placing a pulmonary artery floating catheter for monitoring, its clinical application is limited. Central venous oxygen saturation requires only a small collection of blood samples, which can reflect the oxygen saturation of the superior vena cava, and studies have shown that it can effectively guide the blood transfusion of patients undergoing cardiac surgery. Existing studies have shown that in critically ill patients, the use of arterial-venous oxygen difference > 3.7 mL as an indicator to guide blood transfusion can lead to a higher 90-day survival rate. However, the relationship between the arterial-venous oxygen difference and the incidence of adverse events in cardiac surgery patients under CPB remains unclear. Whether increasing the arterial-venous oxygen difference during surgery can reduce the incidence of postoperative adverse events remains to be clarified.
This study intends to collect intraoperative arterial blood and central venous blood samples from cardiac surgery patients undergoing CPB, and analyze the relationship between arterial-venous oxygen difference and the incidence of postoperative adverse events.
详细描述
The >18 y/o patients who undergo cardiac surgery with cardiopulmonary bypass and with a preoperative additive EuroSCORE I≥ 6 are enrolled. Blood samples will be collected through arteries and central venous at the following intraoperative time points: before CPB, during CPB, and after CPB. The observation will end by hospital discharge or 28 days after surgery, whichever came first. The follow-up will continue for one year after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Cardiovascular surgery patients with cardiopulmonary bypass
- •Preoperative EuroSCORE I≥6（European System for Cardiac Operative Risk Evaluation)
- •Obtained informed consent
排除标准
- •Patients who cannot accept blood products
- •Patients who refuse to accept transfusion
- •Patients with autologous blood reserve before surgery
- •Patients who are going to receive heart transplantation or have undergone heart transplantation
- •Patients who have undergone ventricular assist device implantation surgery
- •Patients who refuse to participate in this trial
结局指标
主要结局
Composite outcome of mortality and serious morbidity (cardiac, renal, and neurological events)
时间窗: From the start of surgery until hospital discharge or postoperative day 28, whichever comes first
Composite incidence of any one of the following events occurring during the hospitalization : (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (stroke)
次要结局
- Blood product transfusion(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Duration of mechanical ventilation after surgery(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Occurrence of low cardiac output after surgery(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Infection(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Reoperation rate(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Acute kidney injury(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Incidence of any independent component of the primary outcome(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Total length of hospital stay after surgery(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Length of stay in ICU(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Encephalopathy(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Gut infarction(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Seizures(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
- Delirium(From the start of surgery until hospital discharge or postoperative day 28, whichever comes first)
研究者
Min Yan
Director of Department of Anesthesiology, The Second Affiliated Hospital, Zhejiang University School of Medicine
Second Affiliated Hospital, School of Medicine, Zhejiang University